GSK

Regulatory Specialist, SDE – Investigational

GSK

full-time

Posted on:

Location Type: Office

Location: Bengaluru • 🇮🇳 India

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Job Level

Junior

About the role

  • Contribute to the preparation of Clinical Trial Application (CTA) packages for EU and Non-EU regions, including Application forms and Market Specific documents, and compiling submission components (e.g., Investigator’s Brochure (IB), protocol, Investigational Medicinal Product Dossier (IMPD), etc.).
  • Support the preparation and delivery of submission packages for CTA amendments, EU End of Trial Notifications (EOTN), and EU Study Summary submissions.
  • Collaborate with project teams to assist in the planning and compilation of Development Safety Update Reports (DSURs), new US Investigational New Drug applications (INDs), and IND amendments.
  • Follow Regulatory System processes precisely and consistently, ensuring alignment with Global Regulatory Affairs (GRA) Standard Operating Procedures (SOPs), Work Instructions, and How-to Guides.
  • Maintain a patient-focused mindset while learning to identify opportunities for process efficiency and simplification.
  • Advocate for and support the use of Regulatory Systems among stakeholders and submission deliverable providers.
  • Partnering with peer colleagues in Submission Delivery Excellence and the Regulatory Asset Oversight team to maximize resources and to identify and remove barriers that will prevent a successful outcome on submission delivery targets.
  • Maintaining awareness of emerging investigational regulatory requirements across regions in scope of role.
  • Should communicate risks and issues to senior colleagues and management.

Requirements

  • Bachelor’s degree in life sciences, pharmacy, biotechnology, or a related scientific discipline.
  • 1–4 years of experience in regulatory affairs, clinical trial applications, or a related role in the pharmaceutical or clinical research environment.
  • Has knowledge of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to global submission requirements.
  • Good knowledge of relevant regulations and standards relating to the submission of regulatory applications and drug development worldwide.
  • Ability to coordinate the submission delivery activities as an integral member of a Regulatory Operational team.
  • Ability to work well both independently and within a team to ensure on-time delivery of objectives/projects.
  • Ability to work with and add value to matrix teams in a globally diverse organization.
Benefits
  • hands-on regulatory experience that supports clinical development across multiple geographies
  • supportive collaboration and continuous learning
  • professional growth and a sense of purpose in work that helps advance global health

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Clinical Trial Application (CTA)Investigational Medicinal Product Dossier (IMPD)Development Safety Update Reports (DSUR)Investigational New Drug (IND)Regulatory AffairsGlobal Regulatory Affairs (GRA)Regulatory System processesSubmission delivery activitiesRegulatory applicationsDrug development
Soft skills
patient-focused mindsetprocess efficiencycommunicationcollaborationteamworkrisk managementproblem-solvingindependenceorganizational skillsadvocacy
Certifications
Bachelor’s degree in life sciencesBachelor’s degree in pharmacyBachelor’s degree in biotechnology